Cover Screw CS1

GUDID 08806388211814

AnyOne Internal H=1

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388211814
• NIH Device Record Key: d5056a4c-30eb-4f72-b389-f39a456399af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cover Screw
• Version Model Number: CS1
• Catalog Number: CS1
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806388211814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123988

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-06-24

On-Brand Devices [Cover Screw]

• 08806388240548: ExFeel External M2/ Wide
• 08806388235094: ExFeel External M1.6
• 08806388233229: Rescue External Ø6/ M2.5
• 08806388231430: ExFeel External M2
• 08806388226436: MiNi Internal Ø2.6/ H=0.5
• 08806388225217: Rescue External Ø5
• 08806388222322: ExFeel Internal Ø5.8
• 08806388214853: EZ Plus Internal Regular, Wide
• 08806388214846: EZ Plus Internal Small
• 08806388211838: AnyOne Internal H=0.5
• 08806388211821: AnyOne Internal H=2
• 08806388211814: AnyOne Internal H=1
• 08806388209675: Rescue Internal Ø4
• 08806388201235: AnyRidge Internal Ø3.5/ H=2.6
• 08806388201228: AnyRidge Internal Ø3.5/ H=1.6
• 08806388201211: AnyRidge Internal Ø3.5/ H=0.8
• 08806388260577: Ø6/ H=0.5/ RC
• 08806388260560: Ø3.7/ H=1/ RC
• 08806388260553: Ø3.7/ H=0.5/ RC
• 08806388260546: Ø5/ H=0.5/ NC
• 08806388260539: Ø3/ H=1/ NC
• 08806388260522: Ø3/ H=0.5/ NC
• 08806388255214: Regular & Wide
• 08806388255207: Small
• 08809728995269: Common Ø6.0/ L=8.5 / M2.0
• 08809728995221: XPEED AnyRidge Internal Implant System Ø6.0/ L=7.5 / M1.8
• 08806388260720: AnyRidge Internal
• 08806388260713: AnyRidge Internal
• 08809931186218: AANCSF384008
• 08809931183729: ARi ExCon Implant System
• 08809931183712: ARi ExCon Implant System
• 08809931183705: ARi ExCon Implant System
• 08809931183699: ARi ExCon Implant System
• 08809931182456: ARi ExCon Implant System
• 08809854029876: ARi ExCon Implant System
• 08809854028923: ARi ExCon Implant System
• 08809854028916: ARi ExCon Implant System